Brief Description
To analyse and report on QC test samples (e.g. packaging items, raw materials, intermediates, finished products and stability samples) in accordance with cGMP.
Essential Functions/Responsibilities
* Perform analytical testing using HPLC, GC, TLC, FTIR, UV and other required techniques in accordance with written procedures.
* Provide clear and accurate records of all work performed.
* Record data into appropriate records and notify management of any OOS, OOT, OOE or questionable results.
* Ensure that all results are reported and approved in a timely manner.
* Identify any non-compliances or deviations and notify management.
* Ensure that all equipment is fully calibrated and serviced prior to testing.
* Apply appropriate SOPs and test methods to all testing to ensure compliance and quality of resulting data.
* Maintain a clean and tidy work environment, including carrying out housekeeping tasks as assigned.
* Maintain stocks of consumables, chemicals, solvents, etc through regular stock checks and re-ordering when required.
* Carry out checking of analytical documentation (where experience and training allows).
* Assist with sampling of raw material samples as required.
* Actively look for and implement improvements in productivity and efficiency within own work area.
* Work in accordance with the systems in place with regards to health & safety, security and the environment.
* Undertake other activities, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager.
* Operate in accordance with the company corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence.
Required Knowledge, Skills, and Abilities
* Typically >1 year relevant post degree work experience, ideally in the Pharmaceutical, Biotechnology or a related industry.
* Experience of using routine analytical instruments (e.g. HPLC, GC, TLC, FTIR, UV etc.) and of routine analytical techniques (titration, pipetting, etc).
* Working knowledge of office IT packages.
* Good level of written and verbal communication skills.
* Excellent attention to detail and ‘concern for quality’.
* Understanding of cGMP.
Required/Preferred Education and Licenses
* Bachelor’s degree in science or related discipline.
Attributes and Behaviors
Operates in accordance with the Jazz values of:
* Integrity: Walks the Talk. Honest, ethical and genuine in interactions and compliant in conduct. Provides transparent, open feedback and holds self and others accountable.
* Innovation: Challenges the Status Quo. Has an open, curious mindset. Takes educated risks and finds new ways to solve problems. Gets comfortable with failure. Recognizes wins and learns from mistakes. Anticipates future needs.
* Pursuit of Excellence: Makes an Impact. Is agile and adaptable to change. Continuously asks, “How can we make this better?”. Acts and continuously iterates. Focuses on action, agile performance.
* Passion: Put Patients First, Always. Truly cares about what is done and consistently strives to do their best for our patients.
* Collaboration: Seeks Better Perspectives. Seeks new, diverse perspectives to drive better outcomes. Creates a safe space to share opinions. Partners with respect and takes accountability for actions. Celebrates our differences.
Proven organisational and interpersonal skills, demonstrated through the following competencies:
* Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services.
* Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; doesn’t misrepresent themselves for personal gain.
* Peer Relationships: Can quickly find common ground and solve problems for the good of all; can solve problems with peers with the minimum of noise; is seen as a team player and is cooperative.
* Managing through Systems: Can design practices, processes, and procedures that allow managing from a distance; is comfortable letting things manage themselves without intervening; can make things work through others, without being there; can impact people and results remotely.
* Problem Solving: Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
* Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience and judgement.
* Building Effective Teams: Blends people into teams when needed; creates strong morale and spirit in their team; shares wins and successes; lets people finish and be responsible for their work.
* Planning: Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process
#J-18808-Ljbffr